Noninferiority drug trials fail to report adequate methodological detail: an assessment of noninferiority trials from 2010 to 2015

Noninferiority (NI) trials are prevalent in many therapeutic areas and are used to evaluate new drugs [1 –4]. When reading NI trials, one must pay special attention to the justification for the NI margin [5,6]. With the NI margin being a key part of NI trial design, any questionable justification for the choice of the NI margin can lead to incorrectly declaring a new drug a reasonable alternative to the current standard therapy. Many comprehensive reviews have assessed the quality of reporting in NI trials and revealed considerable problems in reporting of the justification for NI margins [7–9].

Source: Journal of Clinical Epidemiology - December 7, 2018 Category: Epidemiology Authors: Jenny Hong, Anthony Tung, Angus Kinkade, Aaron M. Tejani Tags: Letter to the Editor Source Type: research